The FDA has approved gemifloxacin mesylate (Factive®, GeneSoft) to treat mild-to-moderate community-acquired pneumonia (CAP) caused by multidrug-resistant Streptococcus pneumoniae. Fac-tive®, an orally administered, broad-spectrum generic fluoroquinolone, is the first antibiotic specifically indicated for CAP caused by this resistant organism.
In April 2003, Factive® was approved in the U.S. to treat mild-to-moderate CAP caused by other pathogens and for acute bacterial exacerbations of chronic bronchitis.
Pneumonia is the primary cause of death from infections. More than 25% of S. pneumoniae isolates in the U.S. are multi-drug-resistant, defined as strains that are resistant to two or more of the following antibiotics: penicillin, second-generation cephalosporins, macrolides, tetracyclines, and canadian trimethoprim/sulfamethoxazole.